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Mark Senak, social media advocate and author of the EyeonFDA blog, has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work!

As duly noted by Mark, FDA seems focused on inconsequential and banal issues like fair balance. The whole concept of fair balance has never been clearly defined and companies continually do everything possible to test the agency's resolve on the issue by finding new ways to push the envelope.Therefore, it makes no sense to me that the agency would choose to focus on the question of fair balance and social media when more pressing issues like adverse event reporting, responsibility for site content(when tools like Google Sidewiki are available to Internet users ) and off-label promotion of approved drugs and devices. As Mark rightly points out, is anybody really going to read the fine print about side effects and adverse events associated with a drug when they click through on an ad that promotes a medicine that might help them? Do people really read the product insert forms that accompany all prescription drugs?

Don't get me wrong. I am not trying to play down the importance of fair balance but DTC advertising is old hat and most experts agree that it really doesn't work well to sell prescription drugs. To that end, I think FDA needs to throw out the old play book and create a new one for social media. Unlike previous regulations, the ones that will guide social media need to be flexible and adaptive enough to accommodate the rapidly changing social media landscape. Nobody said it was going to be easy but that is why FDA employees get paid the big bucks!

Until next time....

Good luck and Happy Thanksgiving!!!!!!!!

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Recruiting patients for human clinical trials has become challenging over the past five years or so. Inclusion criteria have become more stringent and cost of running Phase III clinical trials has skyrocketed.  This has forced life sciences companies and clinical research organizations to be creative in recruiting patients. Traditional methods including print and radio advertising are no longer working.

I previously wrote a piece on the use of social media for clinical trial recruitment. It seemed to me that social media would be ideal for that purpose because of its global reach and the word-of-mouth power that social media devotees have come to rely on.

Several weeks after I posted the article, I ran across a company that has been using social media for clinical trial recruitment for a while. Moreover, the company wrote a white paper urging others to consider using social media to find those difficult-to-recruit patients that everyone is seeking.

Check it out! 

Until next time...

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The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

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Talecris Biotherapeutics announced that it will add 259 jobs as part of a $269 million expansion of its manufacturing facility in Clayton, NC. The RTP-based biotech company already employs more than 3,000 people world wide (2000 in the Raleigh-Durham area and 1,500 in Clayton) and plans to use the 259 new hires to staff its newly expanded manufacturing facility at the Clayton site. The jobs being added will have an average annual salary of $51,066, excluding benefit substantially higher than the salaries of other non-biotech employees in the area.

The company manufactures and sells Prolastin an FDA-approved protein therapy, delivered via a plasma infusion, for patients who have alpha1-antitrypsin (AAT) deficiency, which can lead to emphysema. Talecris, was formed in 2005 when private equity firms Cerberus Capital Management and Ampersand Ventures purchased Bayer AG’s plasma division for $300 million. The company was sold last year to Australia’s CSL, Ltd last year for $3.1 billion and raised $950 million in an initial public offering of stock on this past October.

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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

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Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated Pharmalot blog, AstraZeneca CEO David Brennan, who is also this year’s chair of the industry trade group PhRMA, vowed that pharma would fight the house healthcare reform legislation. 

While Brennan’s statement isn’t surprising nor particularly noteworthy, his comments explaining pharma’s position on healthcare reform are revealing and important to understand. He told the Huffington Post “We said there were principles we didn’t want to see violated. And if those principles - price controls, Medicare rebates, moving dual eligibles back from Medicare and back into the Medicaid discount program - if those things happen, I can’t see how we could be supportive of the program.” In other words, we will support anything you propose— and may even be willing to kick in another $60 billion or so to support healthcare reform— but any discussion about government regulation of drug prices is a deal breaker! 

To my knowledge, this is the first public mention of price controls by any pharmaceutical executive during the almost year long debate on healthcare reform. The reason that I find Brennan’s statement interesting is that I have long contended that pharma will give the Obama administration and Congress anything it wants in exchange for assurances that the government will not attempt to control drug prices. For those of you who don’t know, the US is one of the only countries in the world where the government is prohibited from setting drug prices. This means that US drug makers in concert with insurance companies and third party payors can set drug prices based on what the American pharmaceutical market can bear. Not surprisingly, the profit margins on drugs sold in the US are the highest in the world. Obviously, pharma doesn’t want the US government hindering or limiting their profits by setting or capping drug prices. 

I am glad that pharma has finally decided to publicly “come clean” on the price control issue. The public option and issues surrounding data exclusivity for follow-on biologics pale in comparison to the financial havoc that price controls would wreak on the pharmaceutical industry. And, I suspect that pharma and its lobbyists will do whatever it takes to insure that price controls never become a reality in the US. However, at the end of the day, government regulation of drug and device prices will ultimately be required for any meaningful changes to take place to the US healthcare system.

Hat tip to Ed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

Addendum: After writing this post this weekend, an article appeared in Monday's New York Times that revealed that the drug industry has quietly been raising its wholesale prices on prescription drugs over the past year.  This, of course, was done in anticipation of possible federal legislation that might impose some government controls on drug pricing.  According to the Times article: "In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992. The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.  Not surprisingly, the US pharmaceutical industry justifies the practice because as an industry spokesperson put it  "they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years."  Hmmmm, interesting comment considering the US pharmaceutical industry has layed off over 180,000 employees over the past three years, a majority of whom are R&D scientists...go figure!

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Flu season is upon us and, not surprisingly, there is no dearth of information available to the public about the seasonal and H1N1 flu vaccines. Mostly there are stories about the lack of availability of the vaccines, underreporting of deaths associated from H1N1 infections and perhaps, most importantly concerns about flu vaccine safety. Despite attempts by the CDC and a few dedicated virologists like BioCrowd co-founder Vincent Racaniello, flu vaccine manufacturing is an enigma to the lay public.

While I am a card-carrying microbiologist, my knowledge of the manufacturing of flu vaccine is admittedly lacking. With this in mind, I came across an outstanding tutorial about flu vaccine manufacturing published by the College of Agriculture at the University of Wisconsin-Madison (my alma mater). The UW tutorial is easy to understand and will shed light on and help to demystify flu vaccine production for lay people (and a few scientists like me).

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Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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For the past 10 years or so, I have been providing career counseling and development seminars and workshops for life scientists. In the early years, students, postdocs and a smattering of faculty members would attend to learn about industry trends, the job market and more recently, alternate careers for PhDs and postdoctoral fellows. However, over the last few years, a disturbing trend has emerged—the lack of faculty participation at these events. 

Yesterday, I was invited to participate as a panel member to moderate a career development event sponsored by the graduate student and postdoctoral associations at the University Of Rochester School Of Medicine. The event was well attended (over 85 participants) and the discussion lasted for more than 2 hours. Joining me on the panel was a PhD-trained scientist/manager from Bristol Myers Squibb and a healthcare company executive who received his PhD degree from the university about 16 years ago.

Many of the questions asked by the participants were spot on and revealed that graduate students and postdoctoral fellows are extremely anxious about their futures. The panel did its best to describe what it takes to get a job in the life sciences, the process and steps required to successfully win jobs and some ideas for alternate career options for PhD-trained scientists. Unfortunately, not a single University of Rochester medical school faculty member attended the event. In fact, I met the PI of one of the postdocs who sponsored my visit and he said with all sincerity (I think) “Thanks for coming...the students are really looking forward to your talk.” Obviously, I don’t think that it ever crossed his mind that he, like his students and postdocs, might learn and benefit from a discussion about career options and hear (probably for the first time) how anxious and fearful his and other students are about future job prospects.

The fact that faculty members are routinely eschewing career development seminars and forums is troubling and extremely disturbing for a variety of reasons. First, as I have said many times before, I believe that PIs have moral and ethical obligations to help their students determine what careers that they are best suited for. I don’t think that it is too much to ask or very labor-intensive for PIs to learn about the job market outside of academia.

Despite an ongoing lack of tenured track faculty positions and the extremely fierce competition to win them, academicians continue to exclusively train and prepare students for academic careers. This makes absolutely no sense from a “supply and demand” perspective. Second, the lack of faculty support and participation sends a clear message to graduate students and postdocs that their anxieties, fears and concerns about job prospects simply isn’t that important to their PIs.  The mantra of most academicians —“just continue to do good science and everything will be okay”— is outdated, anachronistic and self serving (for PIs) at best.  

Finally, and perhaps most importantly, the failure of  tenured faculty members to actively engage and participate in discussions about career options reveals the unbridled contempt that most academicians have for scientists who work outside of academia. Most academics choose to not concern themselves with non-academic and mundane issues like jobs and careers. And why should they? Once they win tenure, their lives are set because they are guaranteed jobs and benefits for life!

We are living in very challenging and troubling times. In the past three years, over 180,000 pharmaceutical workers have  lost their jobs and national unemployment will likely hit 15%. Academic and government jobs are hard to come by and the competition for these jobs is ferocious and extremely competitive. And, sadly, current academic training programs are woefully inadequate to prepare graduate students and postdocs for alternate career opportunities in the life sciences. 

As I have stated numerous times before, life science graduate training programs are in dire need of systemic change and must be overhauled to remain relevant. Unfortunately, systemic changes are unlikely because tenured faculty members can’t be forced or induced to change their attitudes or beliefs. While a minority of life sciences faculty members realizes that the system is broken, the majority doesn’t.  To that end, if graduate students and postdoctoral fellows want change to occur, than they must band together and collectively send a message to their PIs and mentors that “We are mad as hell and we aren’t going to take it anymore!” Anything short of a widespread, massive protest will be ineffectual!

To learn how to more effectively manage employees, please check out the 360 feedback solution.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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After announcing yesterday that it will be reorganizing and closing 6 of 20 R&D sites worldwide, Pfizer/Wyeth announced today that as many as 2000 R&D scientists will lose their jobs. I suspect that others will lose their jobs in the next few months or so.

The Pfizer/Wyeth and Merck Schering Plough mergers signal the beginning of the end of the traditional vertically integrated pharmaceutical business model. It is evident that pharma is shifting away from its almost 100 year focus on R&D and manufacturing to less labor intensive and costly activities like advertising, marketing, sales and distribution—things that drug makers have excelled in the past decade or so. Innovation will likely no longer come from within but from external sources including academia, biotechnology companies and third party vendors including CROs and CMOs.   

While the loss of thousands of R&D scientists will have little impact on the productivity and operations of life sciences companies themselves, it has serious implications for academic institutions that train life sciences graduate students and postdoctoral fellows. In the past, PhD scientists who were unable to find academic jobs too refuge and found gainful employment in the life sciences industry. However, American industrial R&D jobs are becoming harder and harder to find as larger companies continue to outsource those activities, to Asia, South America and Eastern Europe. And, the competition for the remaining jobs is becoming increasingly fierce. Put simply, academic institutions have to begin to realize that we no longer need as many PhD-trained life scientists as we have in the past. At present, there is a glut of PhD life scientists in the US, many of whom can’t find jobs. Perhaps, this should be taken into account before graduate school admissions committees determine the number of new graduate students they will admit next year.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

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In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a historical perspective on events leading to the US Food and Drug Administration public hearing on the use of social media and medical promotion that will be held on Thursday and Friday, November 12 and 13, 2009. As Mark points out, registration for the meeting was closed because of an overwhelming response and the number of people who wanted to offer testimony on the topic. Many social media enthusiasts view the public hearing as something of a “game changer” that may influence the future direction of social media in the life sciences industry. But, as Mark, astutely points out, only four pharmaceutical companies and one or two trade organizations will be participating at the hearing. 

The lack of industry participation at the meeting is curious given that 14 companies received warning letters several months ago about their misuse of ad associated with the results obtain by Google search. Further, pharmaceutical companies have consistently and publicly stated that their aversion to social media is contingent upon the lack of FDA’s regulatory guidance for its use. By not actively participating in the public hearings later this week, many pharma companies have chosen to remain silent and will likely allow FDA to craft social media policies that guide the promotional activities of drug makers on its own. This begs the question: why would drug makers allow a federal regulatory agency to unilaterally dictate policy, when the policy will likely affect their bottom lines, i.e. sales and profits? The industry’s refusal to actively participate in these hearings is another example of the cat and mouse game that drug makers like to play with FDA. Put simply, drug makers expect and want FDA to commit (in writing) to certain policies and guidelines and once established, company regulators and lawyers are instructed to find loopholes and work-arounds. I liken the drug industry’s refusal to actively participate in the upcoming public hearings to the now infamous rope-ad-dope strategy Mohammed Ali used to knock out George Foreman in the now infamous Rumble in the Jungle in 1974. This is how wikipedia defines the rope-a-dope: “The rope-a-dope is performed by a boxer assuming a protected stance, in Ali's classic pose, lying against the ropes, and allowing his opponent to hit him, in the hope that the opponent will become tired and make mistakes which the boxer can exploit in a counterattack.” I hope that I am wrong about the drug industry’s strategy and motives.

Without active industry participation it isn’t clear how effective the FDA public hearing on social media will be. As Mark adroitly points out in today’s post, “The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren't the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice - the medical products industry.” I would also add the American public to the stakeholder list who also has considerable “skin in the game.”

Pharma’s active participation at many of the social media conferences that I recently attended indicates that something must be in it for pharma; otherwise they wouldn’t attend. There is no question that social media isn’t a passing fad and is now an integral part of the Web 2.0 experience. That said, for the first time in many years, drug makers have a unique opportunity to actively voice their ideas and concerns and collaboratively work with FDA to craft meaningful social media regulatory guidance. As many of us “outside observers” know, the agency doesn’t have all the answers and we would like to think that drug makers would extend a helping hand to avoid confusion and misunderstandings about the use of social media to promote their products and services. While only 4 companies are scheduled to speak at the hearings, I suspect that there will be many life science company representatives in attendance. Nevertheless, despite what may happen at this week’s hearings, I hope that, going forward, drug makers and device manufacturers will begin to view FDA as a partner rather than an adversary!

Until next time...

Good Luck and Good Job Hunting!!!!

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Employees of Pfizer/Wyeth were notified earlier today of impending changes and consolidation that will be taking place at the newly combined company. According to internal sources, Cambridge, MA, Groton, CT and Pearl River, NY will be the main centers of the combined company’s East Coast operations and San Francisco and La Jolla/San Diego CA will represent West Coast operations. In Europe, the research facility in Sandwich, England will be the main R&D center with a network of smaller sites, in locations such as Montreal, Ottawa, Cambridge UK, Aberdeen UK, and Dusseldorf, Germany providing expertise in vaccine production and biomanufacturing. The company’s China R&D Center in Shanghai will remain the focal point of operations in Asia,

There will be substantial reductions in headcount and the company’s R&D footprint. These include:

• The former Pfizer headquarters in New London, CT, which will be consolidated into the nearby Groton, CT site. Functions currently located at New London will be relocated to Groton
• Elimination of all R&D activities at Princeton, NJ; Sanford and the Research Triangle Park, NC; Chazy, NY; Rouses Point and Plattsburgh, NY; Gosport, Slough and Taplow, UK
• R&D activity will be substantially reduced at the Collegeville, PA and Pearl River, NY sites. Pearl River will remain a center for vaccine and biopharmaceutical development

I suspect that many of the employees who will lose their jobs as a result of the consolidation have already been or will be notified shortly of their fates. It is unfortunate that pharmaceutical companies continue to lay off thousands of employees when the US unemployment rate continues to rise and will likely hit 12 to 13 percent before it is all said and done. As expected, the combined company is reducing its US R&D operations and will likely outsource or purchase these activities from external sources. It is not a good time to be an American R&D scientist.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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I just returned from the 2009 Annual Biomedical Research Conference for Minority Students (ABRCMS) that was held in Phoenix last week. I attended ABRCMS for the first time last year and decided that it was a meeting not to be missed in 2009. Once again the students (mainly undergraduate life sciences majors) were outstanding, knowledgeable and exceedingly professional—something that is frequently missing or absent in their non-minority counterparts. Like last year, every major academic institution, professional society and research organization attended the meeting to recruit minority students to their programs. However, despite the similarities to last year’s meeting, there were several noticeable differences that are worth pointing out.

First, the number of women undergraduate life sciences major who attended the meeting was substantially greater than the number of men in attendance. This shift is indicative of enrollment changes that are taking place in medicine, law and life sciences graduate programs where women now outnumber men. Second, many more students were seeking career development counseling and resume critiquing this year as compared with last year. This likely has much to do with the ongoing financial crisis and rising unemployment which now exceed 10% nationally. Third, many more students I talked with this year were interested in attending graduate school rather than medical school. This shift may have something to do with anticipated changes to the US medical profession that may result from healthcare reform. Alternatively, more minority students are interested in research as compared with medicine and related healthcare professions. 

Finally, the conference keynote address offered by Mae C. Jemison, MD a former astronaut and life science entrepreneur was one of the most inspirational and informative talks that I have ever heard about career opportunities in the life sciences. Dr. Jemison clearly articulated her belief that society ought to stop differentiating between artists and scientists. Further, she added that the two professions are not mutually exclusive from one another! This is likely because, she, in addition to her medical interests, is a professional dancer/choreographer and also a fashion designer. Coincidentally, earlier that morning I was talking with several female scientists who also happened to be life long dancers and choreographers.  I urged them to continue to draw on their dancing experience to channel that creativity to their research. It was humbling to learn that someone as successful and talented as Dr. Jamison shares many of my beliefs and ideas.

On the plane trip back to New Jersey, I happened to sit next to a young assistant professor from Princeton University who will likely earn tenure next year (he was invited to apply for an early decision). Like most other scientists, he initially challenged my notion that PhD students and postdoctoral fellows ought to be offered courses— or at the very least some information about non-academic careers—before they complete their training. After all, only about 10% to 15% of US life sciences PhDs are able to land tenure track positions upon completion of their training. Initially, many of his remarks were expected: “If you want a job you should go to medical school or law school or do something else...nobody said that getting a PhD would help you find a job” and “we train students for academic jobs because it is a way for us to ensure and preserve our legacy as scientists.” It was a good thing that I had my seat belt on at the time because I almost bolted out of my seat after hearing that!  I tactfully (which isn’t easy for me as those who know me will tell you) suggested to him that that kind of thinking is blatantly self-serving and extremely egotistical. Further, I suggested that it is ethically and morally disingenuous for tenured faculty members to continue to train students for jobs that they know don’t exist anymore.  Luckily, he is young and open minded and ultimately conceded that the system is kind of broken and perhaps things need to change. He also offered that he, (unlike most of the people who I trained with the exception of my PhD advisor) discusses career options with his students (some of whom aren’t interested in academic careers) and helps them in any way he can to realize their goals and dreams. Finally, I suggested to him that offering students and postdoctoral fellows some formal courses or training in alternate career options will likely have better performance and outcomes for students and faculty members as compared with continuing to keep them in the dark about career choices and job prospects.

While there is still much work to be done, it appears that younger faculty members are finally recognizing that traditional academic training paradigms may be anachronistic and changes may be necessary for the US to continue to train the best and the brightest!

Until next time...

Good Luck and Good Job Hunting!!!!

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Over the past year or so, more graduate students and postdoctoral fellows have been asking me about management consulting careers in the life sciences. I spent several years working as an independent management consultant and while it was a great experience the revenue stream was unreliable at best and the ability to work was highly contingent upon the economy. However, I can assure that my experiences as an independent management consultant were marketing different than those of consultants who work at the consulting firms like McKinsey or the Boston Consulting Group. For those of you interested in life style of a high-powered management consultant I highly recommend you visit their websites for more info. 

I invited Susan Colilla, PhD, MPH, President of the consulting firm Integrative Epidemiology LLC describe her experiences about becoming a life sciences consultant so that BioJobBlog job readers (who may be considering this as a career option), might get an idea and appreciate what it takes to get into and be successful in this line of work.

My Life as a Life Sciences Management Consultant

by Susan Colilla

After doing a second postdoc at University of Pennsylvania as an Instructor (nebulous junior non-faculty type position) and becoming frustrated with all the extensive work requirements for a tenure-track position, I started searching for a job in pharmaceutical industry.

While searching for a position, a potential employer, who didn’t have an opening at the time, asked if I would be interested in consulting.  As I was interested in this area, I started consulting for industry and realized that I enjoyed working on different projects in epidemiology and genetics, and loved that I could work from my home office and give up a commute. 

The flexibility in consulting is great.  I plan the work around my schedule, and the pay has been rewarding as well.  Last year, I formally incorporated my business, Integrative Epidemiology, LLC.  I offer services in literature reviews, study planning/design, data analysis and grant or manuscript writing in the areas of human genetics or epidemiology. 

As I build my business, I have learned about how to run a business, bookkeeping/billing, taxes, legal issues/contracts, and marketing.  Moving from academia to pharma/industry is tricky unless you have connections with those who hire in the industry.  One of the biggest challenges for me as a self-employed consultant is dedicating a good proportion of my time to networking with others and marketing my services, rather than doing science-related work.  It helps that I am very social by nature and enjoy meeting new people.

 I am also fortunate to be married to someone who makes a good income and receives benefits as this helps support our family.  There can be a sporadic flow of income with consulting, especially during a recession and new business slows down.  I have also partnered up with another consulting group (Venebio, LLC, based in Richmond, VA) to expand the pool of potential clients and work with a group of scientists to offer a broader range of services. 

For those of you who want to learn more about getting into the consultant business, Susan highly recommends an article that recently appeared in the Scientist. She shared with me that the article offers a great list of things to consider before starting a consultancy and that she “wished that she had seen it a couple years ago when I started out in this business!”

Until next time...

Good Luck and Good Job Hunting!!!!  

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I am attending the Annual Biomedical Research Conference for Minority Students (ABRCMS) in sunny Phoenix, AZ where I will be providing career development guidance to undergraduate and graduate students. Ironically, given the dismal job prospects in the life sciences industry for entry level employees, I will be giving a talk on how to find a job!  Last year's meeting in Orlando was a great one and I expect this one to be just as good.

While I am on the road, it doesn't mean that I won't be keeping track of the goings on back in my neck of the woods. To that end, Merck announced today that it will keep Schering Plough's corporate headquaters in Kenilworth, NJ open. Merck announced the decision today after closing on the $7 billion deal yesterday. This is good news for the NJ residents who currently work at the Kenilworth site. New Jersey has been extremely hard hit by all of the pharmaceutical layoffs in the past few years. Unemployment continues to rise and things will not get any better since conservative Republican Chris Christie was elected governor on Tuesday (he plans on laying off massive numbers of state employees) once he takes office in 2010.

Johnson and Johnson, on the other hand, announced that it was closing research & development facilities in Radnor and Chesterbrook, PA and consolidating those operations at the company's Spring House site. The New Brunswick, N.J., company would not say how many jobs are at those locations now or how many would remain in Spring House after the move, which is to be completed by 2012. These closure come shortly after JnJ announced earlier this week that is was elimating ca 8,200 employees or roughly seven percent of its global workforce.

Let's hope that things begin to improve soon. 

Hat tip to the Pharmalot blog!

Until next time....

Good Luck and Good Job Hunting!!!!!!

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As somebody who has been unemployed more than once, unemployment can be depressing, very frustrating and extremely worrisome.  In addition to sending out resumes and networking, I highly recommend using the free time that you have at your disposal to learn new skills to either make your life more manageable or to increase your employability.  Obviously, unemployed persons usually don’t have the money to enroll in formal training programs but thanks to the Internet and social media there are a variety of free tools and options out there for people looking to pick up new skill sets. 

Amber Johnson at OnlineDegreePrograms.org has put together a list of 100 skills you should learn (for free) while unemployed. While many of her suggestions are intuitive, there are a few on the list that may surprise you and quite possibly improve your chances of finding a new job!

100 Skills You Should Learn (for Free) While You’re Unemployed

People Skills and Networking

Become a better networker, small talker and listener to improve your job prospects.

1. Listen: Become a better listener by tuning out background noise and making eye contact.
2. Build a portfolio: Have an organized hard copy and file on your computer that succinctly and accurately represents your best work.
3. Share the conversation: Don’t dominate the conversation: learn to take a step back when you’ve said your part, and know when to jump in if the conversation becomes all about them.
4. Understand your emotional intelligence: Become more socially aware and learn to evaluate your own emotions and reactions.
5. Bring personality to a company: Being able to provide something that people can relate to behind the big corporate name is priceless.
6. Make your resume Internet ready: Make sure your updated resume will display nicely when you e-mail it and post it on job sites.
7. Set an example: Learn how to inspire others by doing what you love, being expressive, and helping others along the way.
8. Expand your network: Tap into contacts two or three degrees removed from your regular network.
9. Network or interview on the phone: Stop working on your in-person networking skills for a minute and remind yourself how to win someone over via the telephone.
10. Give a strong handshake: Impress people with your confidence by giving a better handshake.
11. Remember people’s names: From face association to repetition, there are various ways to remember a person’s name.
12. Know when and how to use icebreakers: Become the one other people depend on to make connections and feel comfortable.
13. Make a point to grow existing relationships: Don’t just get to know people on the surface: get to know business and personal contacts on a deeper level.

Life hacks

From making your own coffee to saving gas, here you’ll learn valuable skills that save you money, too.

14. Make your own coffee: Cut back on expensive coffee runs by learning how to make your own cup.
15. Comparison shop: Comparison shopping will save you money and turn you into a more responsible consumer and better product researcher.
16. Learn how to be more energy efficient: Save money on energy bills at home and at your new office when you get hired again.
17. Save gas: Minimize the number of times you have to spend money on gas by making each fill up last longer.
18. Eat cheaply: Watch this video to learn how to make yummy meals out of dollar-store food.
19. Discover your life purpose: Discover how to tap into your life purpose and passion to give you more direction in your job search and life goals.
20. Face reality: Accepting and dealing with reality will help your career and your personal life.
21. Cook: While you have the time, learn to cook healthy, budget-friendly meals for yourself, and use leftovers.
22. Being positive: Stop complaining and turn yourself into a positive thinker.
23. Meditate: Meditation will help get you through the tough times.

Productivity and Task Mastering

Stay productive and learn to stay on task, avoid procrastinating and set goals even when you’re unemployed.

24. Get up on time: Learn how to get up right when your alarm goes off to get a fresh, productive start to the day.
25. Funneling: The art of funneling means that you know how to manage incoming projects and to-do lists, and prioritize them accordingly.
26. Speed reading: You’ll be able to stay on top of industry reports, news stories, job postings and more when you learn to speed read.
27. Break things down: Turn difficult tasks into easier ones by breaking them down and taking it day by day.
28. How to set goals: Setting goals will help you be more successful, in the short-and long-term.
29. Overcome fear of failure: Fear of failure wastes time and prevents you from doing what you really want.
30. Beat procrastination: This step-by-step guide will help you beat procrastination.
31. Prepare a to-do list: A well-organized to-do list will keep you on track and save time.
32. Learn the Pomodoro Technique: Those who are anxious about meeting deadlines should master this technique.
33. Eliminate distractions: Learn how to tune out distractions and interruptions.

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For the past month or so I have been working on a piece about chemotherapy induced nausea and vomiting (CINV) that is common among patients being treated for cancer. While not a pleasant topic, it is a reality for many patients who undergo cancer chemotherapy treatment.  Although CINV is less common with some of the newly-developed anti-cancer monoclonal antibody treatments, it is still a troublesome and debilitating problem that must be managed during conventional cancer chemotherapy treatment regimens. 

There is a growing body of evidence that marijuana (delta-9-tetrahydrocannabinol is the active ingredient) and related cannabinoid-like agents may help to effectively manage and control CINV in certain patients who are undergoing cancer chemotherapy. Recognizing this, 14 states have already legalized marijuana for medicinal purposes. Interestingly, according to Newsweek Magazine (November 2, 2009), the US government could save as much as $13.5 billion annually if it stopped enforcing laws against marijuana. To that end, the Justice Department says it will no longer prosecute people who use if for medicinal purposes in the 14 states where that's legal.

While I am not advocating illegal drug use, it seems silly to me that the inherent, medically-beneficial properties of  marijuana haven't been fully utilized to treat patients who are suffering from potentially life-threatening illnesses like cancer.  Further, there are legal and medical precedents for the use of illegal drugs that offer medical benefits. For example, while opium use is illegal in the US but morphine and related products (which are derived from opium and poppy plants) are legal prescription drugs that are regularly used to control acute and chronic pain in millions of Americans. Unfortunately, research on development of cannabinoid-like drugs to treat CINV has been stifled because of the illegality of marijuana.

The number of patients being treated for cancer rises each year. Isn't it time to start offering patients the best and most effective medical treatments available to them rather than continuing to adhere to out dated and unevenly enforced US drug laws?

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Johnson & Johnson announced today it would eliminate as many as 8,200 jobs, or 7% of its work force, to help the company cope with what it expects will be a slow economic recovery amid damped demand for drugs, medical devices and consumer products. J&J employs about 117, 000 workers globally. While the job cuts will be global, many losing their jobs will be outside of the US. 

J & J joins a growing list of pharmaceutical and life sciences companies that have announced new layoffs. Pfizer Inc., the world’s biggest drugmaker, plans to fire 19,000 workers following its acquisition of Wyeth and had already cut 10,000 positions since 2007. J&J began firing as many as 4,400 employees from its pharmaceutical and stent divisions in late 2007. Finally, Merck recently announced that it will be eliminating 16,000 workers after its merger with Schering Plough closes later this year.

J&J’s announcement is more bad news for New Jersey which is still reeling from the earlier loss of tens of thousands of pharmaceutical and life sciences jobs.

Until next time...

Good Luck and Good Job Hunting (forget New Jersey)

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I suspect by the growing numbers of people who read BioJobBlog, that some of you may be beginning to wonder who I am. While nobody has taken me to task about my credentials or musings to date, I figured it may be worthwhile to share my “story” with those BioJobBlog readers who may be at a crossroads in their careers. I credit my graduate school experiences and PhD degree for the tenacity, perseverance and the ability to reinvent myself during an eclectic, and oft times, circuitous career path.  

Taking the Path Less Traveled

I had always liked science but by age 10, I had already decided that I wanted to be a veterinarian. However, after seeing the film Ben Hur at age 11—during which two of the main characters who have leprosy are miraculously cured—I fantasized what it might be like to be able to discover cures for infectious diseases. As corny as it may sound, the movie convinced me that my true calling in life wasn’t veterinary medicine but microbiology. Nevertheless, I attended Cornell University as a pre-veterinary medicine undergraduate with a dual major in animal science and microbiology. During my senior year at Cornell, Dr. Brooks Naylor, my food microbiology professor at the time, invited me to do a senior research project in his laboratory. After several weeks in the laboratory I was hooked and knew that graduate school and not veterinary school was in my future.

I entered graduate school in 1974 and did my PhD work in Bob Deibel’s laboratory in the Department of Bacteriology at the University of Wisconsin-Madison studying the pathogenesis of Salmonella gastroenteritis. Because Bob was Chairman of the Department and a food microbiology consultant, he wasn’t around much. This forced me to become self reliant and an independent investigator very early in my scientific career. Interestingly, when I started graduate school, my goal was to earn a PhD degree and teach microbiology at a small liberal arts college. However, after three years at Wisconsin, I decided to eschew a career as a science educator in favor of becoming a tenure track faculty member at a prestigious research institution.

I received my PhD degree in 1981and chose to do a postdoctoral fellowship with Stephen Morse in the Department of Microbiology at Oregon Health Sciences University where I investigated the pathogenesis of Neisseria gonorrhoeae. After two years in Stephen’s lab, I realized that the field of molecular biology had finally taken off and I needed to develop molecular biological skills to compete for my coveted tenure track faculty position. In 1984, I joined Howard Shuman’s laboratory as a postdoctoral fellow in the Department of Microbiology at the College of Physicians and Surgeons at Columbia University in New York City where I studied the molecular pathogenesis of Legionella pneumophila, the causative agent of Legionnaires Disease.

In 1987, after spending three more years as a postdoctoral fellow, my newly acquired molecular biology training coupled with a respectable publication record helped me to land a tenure track faculty position in the Department of Microbiology at the University Of Miami School Of Medicine. I spent the next seven years feverishly doing laboratory research, teaching medical and graduate students, publishing papers and mainly writing grants to establish an independent research program on the role of lipopolysaccharide in the molecular pathogenesis of L. pneumophila. While I was a productive researcher, who regularly published and was recognized on several occasions for teaching excellence, I failed to consistently win grant support to run my laboratory. Consequently, in 1994, I was denied tenure and forced to leave academia—an emotionally devastating event that that ended a life-long dream of becoming a world class research scientist.

Luckily, at that time, the American biotechnology industry had finally hit its stride and I landed a job as a scientist at a New Jersey-based biotechnology company where I managed an antibacterial drug discovery program. My time in industry—which lasted only two years—provided me a firm understanding of the business side of science and perhaps, more importantly, convinced me that industrial research wasn’t for me. This, coupled with a yearning desire to teach again, prompted me to successfully apply for a job as Chairperson of Biology at a local community college. While a good idea at the time, I quickly realized that while I still loved to teach, administration wasn’t my strong suit and I left the community college job after a year.

Unfortunately, by 1998, I had effectively exhausted most traditional career options for scientists with PhD degrees and I desperately needed a job—mainly because I had a wife and three young children to support. Fortunately, while working at the community college, I successfully helped several professional recruiters place new hires into jobs at biotechnology and pharmaceutical companies. This prompted me to seriously consider professional recruiting as a career option and in early 1999 I landed a job as a recruiter at a local recruiting firm. As a new hire I had to attend recruiter school for six weeks. Surprisingly, this training would prove to play a pivotal role in subsequent decisions that helped to shape my career.

After three successful years as professional recruiter, an Australian biotechnology company recruited and hired me as a science and business consultant to help guide their antibacterial drug discovery program. The new job led to an almost four year stint as an independent management consultant advising private and publicly-traded biotechnology companies on business, scientific and financial matters. Also during this time, I decided to indulge my own entrepreneurial fantasies and in 2001 I founded BioInsights (www.bioinsights.com), Inc, a bioscience education and training company. In 2003, Abe Abuchowski and I founded Prolong Pharmaceuticals (www.prolongpharmaceuticals.com) a drug delivery company with two drugs in early stage clinical development. Unfortunately, the rigorous demands of running BioInsights and starting Prolong ultimately led to the demise of my consulting practice and by 2004 I was forced to consider another career move.

Luckily, in 2002, I had begun to write for several biotechnology industry trade publications. Although I wasn’t getting paid to write, it enabled me to hone and polish my writing skills. In late 2004, a medical communications expert who I knew suggested that I take a stab at medical writing. At the time, I didn’t know much about medical writing but I quickly learned that it pays well and medical writers are always in demand. I took her advice and landed my first medical writing job in 2005. Since then, I have worked at a variety of medical communications agencies and pharmaceutical companies preparing manuscripts, posters, slide presentations and other work. Currently, I am freelance science and medical writer, blogger (www.biojobblog.com) and social media enthusiast who, along with Dr. Vincent Racaniello, started an online social networking site for bioscientists called BioCrowd (www.biocrowd.com)

Unlike most scientists, my career path has taken many unexpected twists and turns. I never intended it to be as eclectic or convoluted as it has turned out to be. Nevertheless, I believe that my unusual career trajectory has transformed me into a better rounded scientist than I would have been if I had been able to pursue my intended academic career. In retrospect, I attribute my career successes to solid problem solving skills, an unrelenting desire to continue to learn and an unwavering ability to take risks. Finally, and perhaps most important, I learned that there is no right or wrong career path in the life sciences—only the one that you choose for yourself!

Until next time...

Good Luck and Good Job Hunting!!!!

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It is amazing the things you learn if you pay attention from time to time.  While attending a meeting on e-healthcare last week in Philadelphia I learned that according to the American public the pharmaceutical industry is less popular than the banking industry. This was startling to me given that the recent financial collapse was caused almost entirely by the banking industry.  That the pharmaceutical industry is more reviled than the banking industry suggests that life sciences company have a bit of PR work to do.  But, not to worry, people still hate the oil industry more than the pharmaceutical industry.

On another note, the US FDA decided to raise the cost of regulatory filings for fiscal year 2010.  The cost of filing an application with clinical data is $1.4 million (up from $ 1.2 million in FY 2009); $702, 750 for an application not requiring clinical data or a supplement requiring clinical data (up from $623,600 in 2009) and 457,200 as compared with $425,000 in FY 2009 for an establishment fee (for facilities where drugs are made).* 

I guess the agency figures that pharma can handle the increases despite poor public image and an ongoing recession.

* AAPS News Magazine, Oct-Nov '09

Until next time...

Good Luck and Good Job Hunting

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